FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TULUX-FILTER
K Number: K892517
·
Decision Aug 21, 1989
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
213
Applicant Total
59
Review Days
132
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Basic Information
- Device Name
- TULUX-FILTER
- K Number
- K892517
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Espe GmbH (Us)
- Date Received
- April 11, 1989
- Decision Date
- August 21, 1989
- Product Code
- EBZ
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | FDA class 2 | Dental |
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Other Clearances by Espe GmbH (Us)
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|---|---|---|---|
| K925027 | PHOTAC-FIL APLICAP | Jun 18, 1993 | Substantially Equivalent |
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| K913966 | SONO(R) -CEM | Jan 14, 1992 | Substantially Equivalent |
| K913857 | ROCATEC(R) -PLUS | Dec 16, 1991 | Substantially Equivalent |
| K913965 | ESPE(R) -SIL | Dec 4, 1991 | Substantially Equivalent |
| K905604 | VISIO-GEM ART-SYSTEM | Mar 29, 1991 | Substantially Equivalent |
| K904096 | PHOTAC-BOND | Nov 19, 1990 | Substantially Equivalent |
| K904097 | PHOTAC-BOND APLICAP | Nov 9, 1990 | Substantially Equivalent |
| K904289 | PERTAC UNIVERSAL BOND | Nov 1, 1990 | Substantially Equivalent |
| K900510 | PERTAC-HYBRID | Aug 9, 1990 | Substantially Equivalent |